Methods of Weight Loss in Overweight Coronary Patients

Phase 3

Completed

• Conditions: Obesity
• Interventions: Behavioral: high caloric expenditure exercise; Behavioral: low caloric expenditure exercise plus dietary counseling

• Registration Number: NCT00628277
• Lead Sponsor: University of Vermont

Brief Summary

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

Detailed Description

We hypothesize that a combination of high-caloric expenditure exercise and behavioral weight loss counseling would lead to a greater loss of fat mass and a greater improvement in cardiometabolic risk factors that standard (lower caloric expenditure) cardiac rehabilitation exercise plus counseling.

The study population consists of overweight (BMI \>27) patients with established coronary heart disease. The exercise and counseling program was of 4 months duration with extended follow up at 1 year.

Study Timeline

• Study Start: 2002-10
• Primary Completion: 2007-07
• Study Completion: 2007-07
• Status Verified: 2008-02
• Study First Submitted: 2008-02-26
• Study First Submitted QC: 2008-02-26
• Last Update Submitted: 2008-02-26
• Study First Posted: 2008-03-05
• Last Update Posted: 2008-03-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 74

Inclusion Criteria

• Coronary heart disease
• BMI > 27
• Peak Vo2 > 14.4 ml/kg/min

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Exclusion Criteria

• Presence of diabetes

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	high caloric expenditure exercise	Arm 1: high caloric expenditure exercise plus dietary counseling
2	low caloric expenditure exercise plus dietary counseling	Arm 2: low caloric expenditure exercise plus dietary counseling

Primary Outcome Measures

Name	Time	Method
Fat Mass	4 months, 12 months

Secondary Outcome Measures

Name	Time	Method
Intrabdominal (visceral) fat	4 months
Insulin stimulated glucose disposal	4 months

Trial Locations

Locations (1)

University of Vermont College of Medicine; 🇺🇸 Burlington, Vermont, United States